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Siemens MAGNETOM Skyra Owner's Manual Page 14

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Safety instructions
Country-specific regulations
National guidelines
(for Germany)
Pressure Equipment Direc-
tive
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Legal regulations
Local and national legal regulations must be observed. It is the
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operator's responsibility to follow local statutory requirements
regarding access to the controlled access area.
The local regulations also define the acceptable exposure limits
regarding noise as well as magnetic stray fields for users and
patients. ( System Owner Manual: Technical data)
The following regulations are in effect in Germany:
Medical Devices Act (MPG)
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Electromagnetic Device Compatibility Act (EMVG)
Medical Device Operator Regulations (MPBetreibV)
Accident Prevention Regulations (UVV)
If required, the RF source must be registered with local authori-
ties in accordance with national EMC guidelines.
The super-conductive magnet is classified as pressure equip-
ment. National guidelines for starting up and operating pres-
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sure equipment must be observed.
In Europe, the Pressure Equipment Directive (97/23/EG) regu-
lates the sale of pressure devices.
In Germany, both the Pressure Equipment Directive as well as
the relevant Occupational Safety Regulations (BetrSichV) for
system start-up and operation apply.
MAGNETOM Family - Safety Information
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